Andrx, Biovail Reach Accord On Two Hypertension Drugs

Davie-based Andrx Corp. and Toronto-based Biovail Corp. have settled a long-term dispute over who has the right to sell hypertension drugs Tiazac and Cardizem CD, the companies said Thursday.

Andrx has been seeking to sell a generic form of Tiazac, which represents almost one-fourth of Biovail's sales. It already sells a generic form of Cardizem.

Under the settlement agreement, Biovail will license to Andrx any Tiazac patents it has or will list with the Food and Drug Administration. In exchange, Andrx will pay a royalty to Biovail based on sales of the generic version.

"First and foremost, we are a pharmaceutical company interested in making bio-equivalent versions of branded products available to consumers in a timely fashion," Elliot Hahn, Andrx's chief executive officer, said Thursday. "Putting the litigation behind us was the most efficient means of getting this drug to market."

But it isn't quite there. The FDA has held up approval of Andrx's generic version of Tiazac for unspecified reasons.

"We wrote to the FDA and hopefully addressed the issues, but there's been no word yet," Hahn said.

As part of a larger investigation, the Federal Trade Commission is looking into Biovail's alleged late-listing of a patent for Tiazac with the FDA to quash generic competition. And several members of Congress last week called for hearings into efforts by brand-name companies to delay generic drugs' manufacture.